Hostname: page-component-848d4c4894-jbqgn Total loading time: 0 Render date: 2024-07-07T15:29:47.587Z Has data issue: false hasContentIssue false
  • English
  • Français

Currents in Contemporary Ethics

Published online by Cambridge University Press:  01 January 2021

Timothy Caulfield ,
Trudo Lemmens ,
Douglas Kinsella  and
Michael McDonald
Get access Rights & Permissions [Opens in a new window]

Extract

An increasing number of community physicians are involved in clinical research.Indeed, 60 of industry-funded research is now spent on community based trials. This surge in community based clinical trials has increased the number of clinical trials applications submitted to the drug regulatory agencies by pharmaceutical sponsors. Many have argued that the commercial interests connected to the conduct and outcome of these trials also increases the potential for conflicts of interest for participating physicians. The context in which these trials take place increases the potential for a host of practices that infringe on ethical, legal and clinical obligations of physicians For example, financial recruitment incentives may lead to violations of the inclusion criteria and the consent process. It may result in inappropriate recruitment of patient participants and a blurring of the ethically significant distinctions between treatment and research. In some cases, it may be hard to distinguish research from the marketing of new products and attempts to influencing prescribing patterns.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 32 , Issue 2 , Summer 2004 , pp. 365 - 368
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

Mark A. Rothstein serves as the section editor for “Currents in Contemporary Ethics.” Professor Rothstein is the Herbert E Boehl Chair of Law and Medicine and the Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine in Kentucky

References

Morin, K. et al. , “Managing Conflicts of Interest in the Conduct of Clinical Trials” JAMA 287 (2002): 78–84.CrossRefGoogle Scholar
Lemmens, T. Miller, P.B., “The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives” JLME 31 (2003): 398–418.Google Scholar
Editorial, “The Doctor’s Choice” The Globe and Mail(24 July 2003): A12.Google Scholar
DeRenzo, E., “Coercion in the Recruitment and Retention of Human Research Subjects, Pharmaceutical Industry Payments to Physician-Investigators and the Moral Courage of the IRB,” IRB 22 (2000): 1–5; Rutherford, R., “Potential Problems with Industry-Supported Clinical Research,” Journal of Vascular Surgery 31 (2000): 1066–76.CrossRefGoogle Scholar
Caulfield, T. Griener, G., “Conflicts of Interest in Clinical Research: Addressing the Issue of Physician Remuneration,” JLME 30 (2002): 305–308.Google Scholar
Goldner, J., “Dealing with Conflicts of Interest in Biomedical Research: IRB Oversight as the Nest Best Solution to the Abolitionist Approach,” JLME 28 (2000): 379–404.Google Scholar
Meslin, E. M. McDonald, M., “Research Ethics as Social Policy: Some Lessons from Experiences in Canada and the United States,” The Tocqueville Review/la Revue Tocqueville (forthcoming).Google Scholar
Canadian Medical Association, Code of Ethics <www.cma.ca/commonPage.do?pageId=/staticContent/HTML/NO12/where_we_stand/code.htm> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
Manitoba College of Physicians and Surgeons, “Conflict of Interest: Relationship with the Pharmaceutical Industry (106 Guidelines)” <www.umanitoba.ca/colleges/cps/Guidelines_and_statements/106.html> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
College of Physicians and Suigeons of New Brunswick, Code of Ethics <www.cpnsb.org/english/code-of-ethics.html> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
College of Physicians and Surgeons of Ontario, “MDs Relations with Drug Companies” <www.cpso.on.ca/Policies/drug_relation.htm> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
College of Physicians and Surgeons of Alberta, Bylaws <www.cpsa.ab.ca/aboutus/attachments/2003Bylaws.doc> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
Lemmens, T. Freedman, B., “Ethics Review for Sale? Conflicts of Interest and Commercial Research Review Boards,” Milbank Quarterly 78 (2000): 547–83.CrossRefGoogle Scholar
McNamara, L. Nelson, E. Windwick, B., “Regulation of Health Care Professionals” in Downie, J. Caulfield, T. Flood, C., Canadian Health Law and Policy (Toronto: Butterworths, 2002).Google Scholar
Medical Practitioners Act, R.S.B.C. 1996, Ch 285, s. 3(1).Google Scholar
Medical Act, R.S.P.E.I. 1988, c. M-5, s. 3.Google Scholar
Health Professions Act, S.A. 2002, c. H-7. Though this law has been enacted, it will not apply to Alberta physicians until the relevant regulations have been developed and implemented.Google Scholar
See Medical Act, S.N.S. 1995–96, c. 10 (amended 1998 c.31), s. 4(3); Medical Act, S.N.B. 1981, c. 87, s. 5(3); College of Physicians and Surgeons of Saskatchewan, policy e-2, public protection, <www.quadrant.net/cpss/who.html> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
Caulfield and Griener, supra note 5; Office of Human Research Protection, Draft Interim Guidance, “Financial Relationships in Clinical Trials” (January 10, 2001); US General Accounting Office, Report to Congressional Requesters, NIH Clinical Trials: Various Factors Affect Patient Participation (September 1999) (GAO/HEHS − 99 − 182).Google Scholar
Morin, K. Rakatansky, H. Riddick, F. et al. , “Managing Conflicts of Interest in the Conduct of Clinical Trials,” JAMA 278 (2002): 78–84.CrossRefGoogle Scholar
College of Physicians and Surgeons of British Columbia, “The Role of the College” <www.cpsbc.bc.ca/role_of_college.htm> (last visited March 23, 2004).+(last+visited+March+23,+2004).>Google Scholar
Medical Profession Act, R.S.A. 2000, c.M-11, s. 30.Google Scholar
Health Professions Act, S.A. 2002, c. H-7.Google Scholar
Norberg v. Wynrib (1992) 92 D.L.R. (4th) 449 (S.C.C.).Google Scholar
McInemey v. MacDonald(1992), 93 D.L.R. (4th) 449 (S.C.C.).Google Scholar
Litman, M. Sheremeta, S., “The Report of the Committee of Inquiry on the Case Involving Dr. Nancy Olivieri: A Fiduciary Law Perspective,” Health Law Review 10 (2002): 3–13.Google Scholar
See Rodwin, M.A., “Strains in the Fiduciary Metaphor: Divided Physician Loyalties and Obligations in a Changing Health Care System” American Journal of Law and Medicine 21 (1995): 241–257.Google Scholar
Litman, M., “Fiduciary Law and For-Profit and Not-For-Profit Health Care” in Caulfield, T. von Tigerstrom, B., Health Care Reform and the Law in Canada (University of Alberta Press, 2002).Google Scholar
Lemmens, Freedman, , supra note 13.Google Scholar
Guerin v. The Queen [1984] 2 S.C.R. 335Google Scholar
Litman, , supra note 28.Google Scholar
Miller, F., “Trusting Doctors: Tricky Business When It Comes To Clinical Research,” Boston University Law Review 81 (2001) 423–456.Google Scholar
Shalala, D., “Protecting Research Subjects — What must be done,” N. Eng. J. Med. 343 (2000): 808–810.CrossRefGoogle Scholar
Miller, , supra note 32: at 439.CrossRefGoogle Scholar
DeAngelis, C., “Conflict of Interest and the Public Trust,” JAMA 284 (2000): 2237–2238.CrossRefGoogle Scholar
Wynia, M. et al. , “Medical Professionalism in Society,” N. End. J. Med. 341 (1999): 12–16.CrossRefGoogle Scholar
May, W., “The Beleaguered Rulers: The Public Obligation of the Professional,” Kennedy Institute of Ethics Journal 2 (1992) 25–41.CrossRefGoogle Scholar
Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (Medical Research Council, Ottawa, 1998).Google Scholar